BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY TRACHEOSTOMY TUBE

    MDR report key: 33671 · Received June 21, 1996

    Report

    Report Number
    MW1009343
    Event Type
    Malfunction
    Date Received
    June 21, 1996
    Date of Event
    May 30, 1996
    Report Date
    June 11, 1996
    Manufacturer
    MALLINCKRODT MEDICAL TPI, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TODAY IN DR'S OFFICE DR WAS CHANGING A TRACHEOSTOMY ON A PT WHO IS A QUADRAPLEGIC AND VENTILATOR DEPENDENT. PT USES #8 CUFFLESS TRACHS. PT BROUGHT ONE HERE. IT DID NOT APPEAR THAT THERE HAD BEEN ANY TAMPERING OR ANYTHING WRONG WITH THE TRACH SET, BUT UPON OPENING THE PLASTIC BAG, DR DISCOVERED THAT THE INNER CANNULA WAS MISSING. OBVIOUSLY, THIS COULD HAVE SERIOUS IMPLICATIONS FOR A VENTILATOR DEPENDENT PT. FORTUNATELY, OFFICE HAD A STERILIZED INNER CANNULA FROM A PREVIOUS TRACH SET, AND USED THAT ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY TRACHEOSTOMY TUBE CUFFLESS TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL TPI, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR